On March 22, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat cancers and viruses, reported recent activity, new positive data and expected near term milestones across its clinical development pipeline (Press release, Moleculin, MAR 22, 2023, View Source [SID1234629164]).

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"We continue to make significant progress on multiple fronts across our development pipeline and ongoing clinical trials. Our team believes that the human activity demonstrated with our lead program, Annamycin, in two separate indications, normally treated with doxorubicin (or its equivalent), continues to support our expectation of generating pivotal data in 2023. Additionally, preliminary data continue to demonstrate a promising safety and efficacy profile with zero evidence of cardiotoxicity, as analyzed by our independent expert, which bolsters our confidence in Annamycin’s potential as we continue to advance development. Additionally, we are pleased with the rapid pace of enrollment in our Phase 2 STS lung metastases clinical trial that, we believe, has us on track to complete enrollment in the first half of 2023 and in a position to report topline data from this study in the second half of this year," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

Mr. Klemp added, "2023 is poised to be an exciting year. We are actively recruiting in three Phase 1b/2 clinical trials and expect to add more trials during the year. These three currently active clinical trials are open label and provide us with the opportunity to announce clinical activity as it is being demonstrated throughout 2023. Additionally, in February 2023, our externally funded Phase 1 clinical trial studying WP1066 for the treatment of pediatric brain tumors concluded, and we expect to have at least three externally funded Phase 1b/2 clinical trials for WP1066 in the treatment of GBM and other brain tumors in 2023, including another pediatric clinical trial, in the U.S. and, possibly, in Southeast Asia."

Ongoing Clinical Trial Updates

Next Generation Anthracycline – Annamycin

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. An independent expert has reported no signs of cardiotoxicity in the first 42 patients in the Company’s three clinical trials, which total includes 32 patients treated over the lifetime maximum anthracycline dose set by the U.S. Food and Drug Administration (FDA). Annamycin is currently in development for the treatment of STS lung metastases (STS lung mets) and relapsed or refractory acute myeloid leukemia (AML) and the Company believes the drug may have the potential to treat additional indications.

STS Lung Mets

The Company is currently in the Phase 2 portion of its ongoing U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107). clinicaltrials.gov: NCT04887298

Recent Activity Highlights

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As previously announced, in the Phase 1b portion of the MB107 study, 15 subjects were enrolled, and we determined the Recommended Phase 2 Dose (RP2D) as safe and tolerable and demonstrated a preliminary response of stable disease or better in 60% (n=15) – defined as stable disease (SD) with STS lung mets or better after two cycles (approximately six weeks) of Annamycin. The median progression free survival (PFS) was 2.6 months for subjects receiving the study drug dose per the protocol in the Phase 1b portion.

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Preliminary Phase 1b data showed no evidence of cardiotoxicity.

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In the ongoing Phase 2 portion of the study, to date 14 of the up to 28 subjects have been identified, recruited, or dosed. Of those recruited, 11 have begun receiving doses and 6 have been dosed two cycles and received their end of Cycle 2 scans.

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In this Phase 2 portion of the trial to date, Annamycin has demonstrated a preliminary response of 67% (4 of 6) of subjects showing SD through 2 or more cycles, with one subject continuing with the study drug. The main reason for subjects not continuing is due to myelosuppression attributed to the study drug, keeping in mind that most of these subjects have had multiple prior treatments for STS and some have received close to the lifetime maximum anthracycline dose (LTMAD) as determined by the FDA prior to entering the study. All four subjects will continue to be monitored for PFS while in the study. These data are preliminary and subject to change.

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Up to 28 subjects will be enrolled at the RP2D in Phase 2 to focus more on quantifying efficacy as well as providing additional safety information.

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An investigator sponsored Phase 1b/2 clinical trial was initiated in Poland in 2022 to study an alternative dosing regimen for Annamycin in the treatment of STS lung mets. This trial began administering drug to subjects in late 2022, at dosages significantly below that being tested in the Company’s U.S. study, with no human activity noted in the first two subjects in the first cohort of the Phase 1b portion of the study. This study is ongoing.

AML

The Company is currently conducting its Phase 1b/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587

Recent Activity Highlights

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In 2022 Moleculin completed its Phase 1 single agent trial for Annamycin in AML (MB-105) with fifteen subjects receiving a full cycle per protocol, identifying an RP2D and demonstrating an 80% Overall Response Rate (ORR) in the five subjects treated with the RP2D in the final cohort. Three subjects achieved a Partial Response (PR) and one achieved a complete response with incomplete recovery of peripheral blood count (CRi). For purposes of this clinical trial, the protocol defines a CR means that the subject’s bone marrow aspirate assessments (BMA) reduced to 5% or less with recovery of neutrophils (or white blood cells) and platelets, CRi means a CR where there was incomplete recovery of neutrophils and/or platelet counts and a PR means the subject’s BMA reduced by 50% and resulted in a blast count of 25% or less.

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It is noteworthy that one investigator designated two of the three PR subjects as such even though the subjects did achieve BMA’s showing a blast count below 5% at the end of therapy.

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The MB106 clinical trial application (CTA) in Poland for a Phase 1b/2 trial of Annamycin in combination with Cytarabine (AnnAraC) for the treatment of AML was allowed in 2022. This trial was later approved to expand into Italy in 2022 and dosing subjects began in March 2023.

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Five clinical sites in Poland and Italy have been recently activated for the MB-106 trial. The Company is planning for a total of up to eleven sites in the European Union (EU).

Upcoming Milestones Expectations

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STS (U.S.): Report Phase 2 interim data.

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STS (EU): Report Phase 1b/2 interim data.

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AML: Present CSR for MB-105 Phase 1 results at an upcoming conference.

Flagship Immune/Transcription Modulator – WP1066

Moleculin is in ongoing discussions with multiple academic institutions in separate programs evaluating WP1066 for the treatment of brain tumors. The Company expects investigator-sponsored clinical trials or programs for the treatment of adult and pediatric brain tumors to commence in the first half of 2023.

Recent Activity Highlights

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In 2022, an investigational new drug (IND) application Moleculin filed in the U.S. for a Phase 1 clinical trial studying WP1066 for treating glioblastoma multiforme (GBM) in adults received FDA allowance or went into effect.

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The Company supplied drug product to an externally funded pediatric brain tumor trial with WP1066 up to its conclusion in February 2023 and expects up to three more externally funded clinically trials for WP1066 (in combination with radiation) in 2023 in the U.S. and, possibly, in Southeast Asia.

Expected Upcoming Milestones

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Report topline results from investigator-initiated Phase 1 study in pediatric brain tumors.

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Seek to capitalize on external funding with opportunities for an investigator-initiated clinical trial in adult and pediatric cancer patients in 2023.

Metabolism/Glycosylation Inhibitor – WP1122 Portfolio

WP1122 was developed as a prodrug of 2 deoxy-D-Glucose (2-DG) to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses. The WP1122 Portfolio includes numerous analogs, including WP1096, which has demonstrated the potential for broad antiviral capabilities in a wide range of in vitro models including multiple arenaviruses, Zika virus, and HIV. The Company looks forward to the potential externally funded clinical trials to confirm such activity.

Recent Activity Highlights

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The Company’s Phase 1a clinical trial of WP1122 in the United Kingdom for the treatment of COVID-19 began recruiting in 2022, and the Company safely completed the trial in late 2022, establishing an RP2D. This RP2D will possibly aid in future externally funded trials for the treatment of certain viruses and cancers as the Company looks for investigator led studies.

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In 2021 the Company filed an IND with the FDA that then went into effect, allowing it to proceed with a clinical trial using WP1122 for the treatment of glioblastoma multiforme (GBM). This may lead to an oncology investigator-initiated trial.

Expected Upcoming Milestones

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Report preliminary findings of National Institutes of Health (NIH) funded animal testing of WP1096 in the Tacaribe Arenavirus.

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Identify investigators interested in initiating a clinical trial to study the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

General Information on the Company’s Core Technologies

Annamycin currently has Fast Track Status (FTS) and Orphan Drug Designation (ODD) from the FDA for the treatment of soft tissue sarcoma, in addition to ODD for the treatment of acute myeloid leukemia. WP1066 has ODD for the treatment of GBM and has four treatments designated for the FDA Rare Pediatric Disease Priority Review Voucher (PRV) Program. WP1122 has ODD for GBM, as well, and FTS for GBM. For more information about our trials, please visit clinicaltrials.gov.

On March 22, 2023 Massive Bio, Inc., a private AI-enabled oncology startup that provides virtual and in-person concierge services for cancer patients, and NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, reported collaboration with the goal of accelerating the development of new cancer therapies and ultimately improving the lives of millions of cancer patients around the world (Press release, Massive Bio, MAR 22, 2023, View Source [SID1234629163]). NeoGenomics will identify patients in real time who may be eligible for clinical trials based on biomarker status. Following initial contact and outreach provided directly from NeoGenomics to the treating physician, Massive Bio will help obtain patient consent and expediate additional screening and potential enrollment. This partnership will help to quickly identify patients eligible for clinical trials and help patients and providers make an informed decision regarding their potential treatment avenue.

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By combining their respective strengths in biomarker testing, data analysis, machine learning, and biomarker and genomic profiling, the collaboration between NeoGenomics and Massive Bio have achieved a significant milestone in the oncology industry.

"Our mission at Massive Bio is to provide cancer patients with the best possible care and treatment options," said Selin Kurnaz, PhD, CEO and co-founder of Massive Bio. "By partnering with NeoGenomics, a leading player in the cancer diagnostics industry that shares Massive Bio’s commitment to advancing cancer research and improving patient outcomes, we can leverage their expertise in oncology diagnostics to accelerate the identification of patients who may be eligible for clinical trials."

"NeoGenomics’ advanced diagnostic tools and U.S. footprint, combined with Massive Bio’s AI capabilities and concierge services in oncology, will enable us to match patients to clinical trials faster and more efficiently, resulting in improved outcomes and reduced costs," said Vishal Sikri, President of the Advanced Diagnostics Division of NeoGenomics. "We are thrilled to partner with Massive Bio to advance precision medicine and improve the delivery of healthcare services to patients, pharmaceutical partners, and healthcare providers."

Dr. Arturo Loaiza-Bonilla, MD, co-founder and Chief Medical Officer of Massive Bio, added, "This collaboration between NeoGenomics and Massive Bio will enable us to provide patients with personalized care and support throughout their cancer journey, and move the needle forward in precision oncology and research."

On March 22, 2023 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported fiscal year 2022 financial results and provided updates for its clinical development programs (Press release, Marker Therapeutics, MAR 22, 2023, View Source [SID1234629162]).

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"2022 was a critical year for Marker Therapeutics as we advanced the company on several fronts, including key enhancements to our multiTAA clinical development pipeline and strategic initiatives, including with Wilson Wolf, to leverage our differentiated manufacturing capabilities to generate alternative sources of funding for our clinical programs," said Peter L. Hoang, President and Chief Executive Officer at Marker Therapeutics. "We believe these initiatives will unlock multiple value building opportunities for Marker throughout 2023. We continue to advance our MT-401 Phase 2 ARTEMIS clinical trial and are encouraged by recent data involving measurable residual disease (MRD) positive patients, which suggest MT-401 produced with our new T cell manufacturing process could be well suited for this underserved subset of patients with AML. We anticipate reporting a more expansive data readout from the MRD positive group in the second half of 2023.

Mr. Hoang continued: "We also made considerable progress with our MT-601 program, securing FDA clearance for INDs in non-Hodgkin lymphoma and pancreatic cancer. We have initiated enrollment for the lymphoma Phase 1 clinical study of MT-601 and expect to report topline data in early 2024 and expect to initiate enrollment for the pancreatic study by the fourth quarter of 2023. We continue to be energized by the manufacturing services agreement with Wilson Wolf and believe we are on track to earn the additional $1 million bonus provided for in the agreement. Additionally, we see the potential to build on the success of this project with additional revenue-generating opportunities whereby we leverage our unique expertise in technical operations to provide the company with non-dilutive capital to fund our clinical programs

MT-401 PHASE 2 ARTEMIS (AML)

New manufacturing process for MT-401:

· In 2022, Marker implemented an improved manufacturing process that reduced production time to 9 days (compared to the original process of >30 days).
· This new process enabled a >90% reduction in the number of operator interventions during production and an improved final T cell product candidate compared to the original product candidate that was used in the ongoing ARTEMIS trial.
· These process improvements have yielded an MT-401 product candidate that has five times the measurable specificity and four times the potency in terms of tumor killing as compared to the prior manufacturing process. Marker has now treated 12 patients with MT-401 manufactured using the Company’s improved process, with 16 patients treated with MT-401 manufactured using the original process, for a total of 28 patients.

Adjuvant Patients:

· To date, a total of 11 patients in the adjuvant arm of the ARTEMIS study have been randomized to treatment with MT-401 using a new manufacturing process or to standard-of-care.
· All patients are too early for evaluation, but the Data Monitoring Committee has reviewed the existing safety data and has not identified any concerns.

Marker continues to see promising data with MRD+ patients:

· A total of four patients with measurable residual disease (MRD+) have been treated and are currently evaluable.
o Two MRD+ patients were treated with MT-401 manufactured using the original manufacturing process and showed elimination of detectable disease.
· In this update, Marker can report on the status of two additional MRD+ patients that were treated with MT-401 manufactured with the improved process:
o The first MRD+ patient was treated at 100 x 106 cells per infusion and was able to remain in stable disease for six months, allowing the patient to bridge to a second allogeneic transplant.
o The second MRD+ patient was dosed at 200 x 106 cells per infusion and the PCR value, which proved to be a valuable tool for detecting MRD, has decreased by 70% only four weeks after the last infusion. This patient’s disease status will continue to be closely monitored and evaluated.
· Marker also treated one additional MRD+ patient with product manufactured using the improved process. This patient is too early for evaluation. Additional MRD+ patients have been enrolled and are awaiting treatment.
· Marker anticipates reporting a data readout of the MRD+ patient subset in the second half of 2023.

Measurable residual disease is an important biomarker in hematological malignancies, such as AML, that is used for prognostic, predictive and monitoring assessments. This term refers to a small number of malignant cancer cells remaining in a patient’s body after completion of therapy, despite the absence of clinical and radiological evidence of disease. MRD detection relies on highly sensitive laboratory techniques, such as next-generation sequencing, polymerase chain reaction (PCR), or flow cytometry. The assessment is crucial in AML management as it can provide prognostic information and guide therapeutic decisions, such as the need for additional treatment or close surveillance. Importantly, MRD is a transitional phase prior to development of frank relapse and considered a negative prognostic factor. Thus, the achievement of MRD negativity, defined as the absence of detectable malignant cells, is a favorable prognostic factor and an important treatment goal in AML

The standard first-line treatment for the last decade had been combination chemotherapy using cytarabine and an anthracycline. However, approximately half of the patients eventually relapse. Eligible patients subsequently proceed to hematopoietic stem cell transplantation (HSCT), but disease relapse after transplant is frequent and remains a major cause of death. To date, there is no approved therapy for post-transplant MRD+ patients, highlighting the need for novel therapies. Therefore, the positive clinical responses observed in MRD+ patients treated with MT-401 may provide a more effective approach to treatment.

"Our ARTEMIS trial showed promising clinical responses in post-transplant MRD positive patients highlighting the potential benefit of our multiTAA-specific T cell therapy in patients where no treatments have been approved," said Dr. Juan F. Vera, Chief Scientific Officer and Chief Operating Officer of Marker Therapeutics. "We will continue to track the patients’ disease status and look forward to investigating MT-401 in a larger patient population."

Dr. Vera continued: "Our improved T cell manufacturing process used for multiTAA-specific T cells enables a 9-day ex vivo T cell production, providing a fast turnaround for patient treatment to reach MRD positive patients before relapse."

Frank Relapse Patients:

· To date, a total of 15 frank relapse patients have been treated.
· In addition to the 11 patients previously reported, who were treated with MT-401 manufactured using the original manufacturing process, four additional patients with frank relapse have been treated with MT-401 manufactured using the improved manufacturing process:
o Of the four patients treated with the improved manufacturing process, one of these patients received a dose of 100 x 106 cells per infusion, while the other three patients were dosed at 200 x 106 cells per infusion.
o None of the frank relapse patients showed an objective response to therapy.
· Marker has suspended further enrollment of frank relapse patients while re-evaluating additional modifications for this patient cohort, including potentially higher cell doses.

MT-601 (Lymphoma)

· IND cleared by FDA for the multicenter Phase 1 trial of MT-601 for the treatment of patients with non-Hodgkin lymphoma
· Phase 1 clinical trial initiated in Q1 2023 with a clinical readout expected in the first quarter of 2024

MT-601 (Pancreatic):

· IND cleared by FDA for the multicenter Phase 1 trial of MT-601 for the treatment of patients with metastatic pancreatic cancer in combination with front-line chemotherapy
· Phase 1 clinical trial expected to initiate by Q4 2023.

FISCAL YEAR 2022 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2022, Marker had cash and cash equivalents of $11.8 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

R&D Expenses: Research and development expenses were $26.1 million for the year ended December 31, 2022, compared to $27.8 million for the year ended December 31, 2021.

G&A Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2022, compared to $12.9 million for the year ended December 31, 2021.

Net Loss: Marker reported a net loss of $29.9 million for the year ended December 31, 2022, compared to a net loss of $41.9 million for the year ended December 31, 2021.

About Marker’s Phase 2 ARTEMIS Trial

The multicenter Phase 2 AML study is evaluating the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting. In the adjuvant setting, approximately 150 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group.

The primary objectives of the trial are to evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival, and overall survival.

On March 22, 2023 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that following the U.S. Food and Drug Administration’s (FDA) approval of Incyte’s Biologics License Application (BLA) for ZYNYZ (retifanlimab-dlwr), the Company will receive a $15 million milestone payment from Incyte. ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017 (Press release, MacroGenics, MAR 22, 2023, View Source [SID1234629161]).

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"The FDA approval of ZYNYZ represents the third approval of a product originating from MacroGenics’ pipeline of proprietary or partnered product candidates," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "We are delighted that with the approval of ZYNYZ, there is now an additional option for treating patients with Merkel cell carcinoma, a rare and aggressive type of skin cancer. We also look forward to Incyte’s continued progress in advancing their development of retifanlimab across additional indications and geographies."

Under the terms of the license agreement, beyond the $15 million approval milestone, MacroGenics is also eligible to receive up to a total of $320 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones from Incyte. In addition, MacroGenics is eligible to receive tiered royalties of 15% to 24% on any global net sales of the product. Finally, MacroGenics has an agreement with Incyte under which it manufactures a portion of Incyte’s global commercial supply of retifanlimab.

On March 22, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that the company will present its VISTA clinical program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, to be held onsite in Orlando, Florida on April 14-19, 2023 (Press release, Kineta, MAR 22, 2023, View Source;utm_medium=rss&utm_campaign=kineta-to-present-vista-biomarker-data-at-aacr-annual-meeting-2023 [SID1234629160]). Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta, will give a poster presentation highlighting new preclinical data on VISTA expression as a potential biomarker in patients with advanced solid tumors.

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Presentation Details:
Poster Title: VISTA expression in patients with advanced solid tumors: A potential biomarker in VISTA-101 clinical trial
Abstract Number: 972
Session Title: Biomarkers of Therapeutic Benefit 1
Session Date and Time: Sunday, April 16, 2023 at 1:30 P.M. – 5:00 P.M. Eastern Time
Location: Section 39